Screening and Support for Youth (SASY) Intervention to Reduce Mental Health Disparities

Mental Health Clinical Trial

— SASY  

Official title:

SASY Intervention to Reduce Mental Health Disparities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419595
• Other study ID #: Exploratory 1
• Secondary ID: PAR-24-210
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2025
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2024
• Source: Cambridge Health Alliance
• Contact: Laura Podewils, PhD
• Phone: 303-436-6000
• Email: laura.podewils[@]dhha.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To adapt the Screening and Support for Youth (SASY) intervention and approach to recruitment for racial, ethnic and linguistic diverse youth aged 12-17 in the Denver Health catchment area

Description:

To adapt the Screening and Support for Youth (SASY) intervention and approach to recruitment for racial, ethnic and linguistic diverse youth aged 12-17 in the Denver Health catchment area.

Includes the recruitment of 220 youth (170 from schools/community and 50 hard-to-reach).

170 participants will be recruited by QR codes available on flyers that will be distributed in schools and community settings. This group will then be randomized to either follow up with the Engaging Youth Expertise for Prevention (EYE) or one of the study team's Research Coordinators (RC) and either EYE or the RC will carry out the assent/consent process with youth and their parents/guardians. For the subsequent (non-randomized) group of 50 hard-to-reach participants, the EYE team will utilize various methods for recruitment, and coordinate the assent/consent process with youth and their parents/guardians.

All 200 participants will be offered a SASY screening which will include the K-CAT, Weiss Functional Impairment Scale (WFIRS-S), CAT-MH social determinants of health (SDOH), and assessment of current mental health treatment. All survey instruments will be delivered via REDCap. Each participant will be assigned a record identification (ID) and an acrostic, so their data can not be identifiable during analysis. All data will stay within the Cambridge Health Alliance (CHA) firewall and only the study team will have access to the results. These products are available in English and Spanish.

A clinical risk score is generated by an algorithm combining symptoms and functional impairment based on national norms. Tier 1 is within normal, Tier 2 is at clinical risk, and Tier 3 is clinically ill. All participants will receive a motivational feedback session to discuss the results of the screening. The discussion will focus on the participant's reflections on how they feel, their perception of their symptoms and functioning, what changes they wish to make in their life, and what might support that change. The feedback will be given to the teens using non-clinical and non-research terms based upon the students' responses on the screening measures. Tier 1 participants will be offered screening and feedback on the screening results. Tier 2 participants will be offered screening, feedback on the screening results and a single session intervention (SSI). Tier 3 participants will be offered screening, feedback on the screening results, a single session intervention and information on community resources. The SSI will be accessed by a unique link provided to the participants, and includes several modules to choose from that participants can complete on their own and at their own pace.

All participants will be invited for a follow-up survey at 1 month following initial screening. The follow-up survey will re-assess the KCAT and WFIRS, therapeutic alliance, and engagement in mental health treatment or behavioral interventions.

All participants will be offered a $20 incentive for the initial screening and $20 for completing the follow-up survey.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• 12 to 17 year old teens

Exclusion Criteria:

• younger than 12 or older than 17

Related Conditions & MeSH terms

• Adolescent Health
• Community Health Services
• Mental Health
• Minority Health

Intervention

Behavioral:
• Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information
Description: Description: Participants who interact with a QR code and express interest in participating will be randomized to receive either: 1) recruitment from a Research Coordinator (standard research staff approach) or 2) recruitment from an EYE for Prevention Youth Researcher. The process of consent, screening, providing feedback, and offering access to a Single Session Intervention and information on additional resources (per scoring on the screening into Tier 1 (low risk/normal), 2 (moderate/at risk), or 3 (high/clinical risk): Tier 1 = screening+feedback; Tier 2=screening+feedback+SSI; Tier 3=screening+feedback+SSI+resource information) will be the same in each group. The randomization is simply changing who provides the process and platform to the participant.
• Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information
Description: Description: Participants who interact with a QR code and express interest in participating will be randomized to receive either: 1) recruitment from a Research Coordinator (standard research staff approach) or 2) recruitment from an EYE for Prevention Youth Researcher. The process of consent, screening, providing feedback, and offering access to a Single Session Intervention and information on additional resources (per scoring on the screening into Tier 1 (low risk/normal), 2 (moderate/at risk), or 3 (high/clinical risk): Tier 1 = screening+feedback; Tier 2=screening+feedback+SSI; Tier 3=screening+feedback+SSI+resource information) will be the same in each group. The randomization is simply changing who provides the process and platform to the participant.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge Health Alliance

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of Single session intervention	Number and proportion of participants in Tiers 2 and 3 that start and/or complete the single session intervention. This will be a measure of engagement in services.	1 month following initial screening
Primary	Participation	Total number and proportion of 12-17 year olds recruited by the Research Coordinator vs. EYE Youth Researchers; also will examine this by proportion racial, ethnic and linguistic (REL) minoritized youth who participate (comparing Research Coordinator vs. EYE)	Immediate at time of enrollment
Secondary	K-CAT/WFIRS scores - preliminary effectiveness	Change on the K-CAT/WFIRS scores between time of screening (pre-) and post-intervention (SSI as the intervention) for Tiers 2 and 3	1 month following initial screening
Secondary	Therapeutic Alliance	Measure of therapeutic alliance with a) recruitment, screening, feedback and b) SSI.	1 month following initial screening
Secondary	Engagement in Mental Health Treatment/Behavioral Change Activities	Self-reported measure of engagement for youth who scored in Tier 3 (and were provided SSI + resources).	1 month following initial screening